Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT06265532
Eligibility Criteria:
Inclusion Criteria:
1. Enrolled in and eligible (based on screening procedures - Visit 1) for the main EGCG Phase 1 study, "Dose ranging study of oral epigallocatechin-3-gallate (EGCG) given daily for 12 weeks to patients with Idiopathic Pulmonary Fibrosis (IPF) evaluating safety, PK interactions with standard of care drugs, and biomarkers of drug effect
2. Signed informed consent
Exclusion Criteria:
1. Pregnant or breastfeeding (a negative quantitative serum human chorionic gonadotropin (hCG) pregnancy test is required for females having child-bearing potential before the participant can participate)\*
2. Research-related radiation exposure exceeds 50 millisievert (mSv) in the prior 12 months
3. Determined by the investigator to be clinically unsuitable for the study
Additional exclusion criteria for participants undergoing PET-MRI:
1. Electrical implants such as cardiac pacemaker, defibrillator, or perfusion pump
2. Metallic or electric implants contraindicated for magnetic resonance-PET (MR-PET) scanning
3. Claustrophobic reactions
4. Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 within the prior 30 days
5. Known allergy to gadolinium
* Women of childbearing potential (WCBP) are defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if \< 55 years or 12 months if ≥ 55 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT06265532
Study Brief:
Protocol Section:
NCT06265532